FDA New Approvals
The FDA has approved Blenrep (belantamab mafodotin-blmf) as a monotherapy treatment for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. Blenrep is the first anti-B-cell maturation antigen therapy.
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The FDA approved Evrysdi (risdiplam) for the treatment of spinal muscular atrophy in adults and children aged 2 months and older.
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The FDA has approved
Lampit (nifurtimox) for use in pediatric patients (from birth to less than aged
18 years and weighing at least 2.5kg) for the treatment of Chagas disease
(American Trypanosomiasis) caused by Trypanosoma cruzi.
Learn more about Lampit
The FDA granted accelerated approval to Monjuvi (tafasitamab-cxix), a CD19-directed cytolytic antibody, indicated in combination with lenalidomide for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low-grade lymphoma, and who are not eligible for autologous stem cell transplant.
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The FDA approved Olinvyk in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. Olinvyk will be commercially available when the DEA issues its controlled substance schedule.
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The FDA has approved Qwo (collagenase clostridium histolyticum-aaes) for the treatment of moderate to severe cellulite in the buttocks of adult women. The drug is the first injectable treatment for cellulite to receive regulatory approval.
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The FDA has granted accelerated approval to Tecartus (brexucabtagene autoleucel, formerly KTE-X19), the first and only approved chimeric antigen receptor T-cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.
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The FDA has approved Viltepso (viltolarsen) injection for patients with Duchenne muscular dystrophy who are amenable to exon 53 skipping therapy.
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The FDA has approved Wynzora (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%) cream for once-daily topical treatment of plaque psoriasis in adults aged 18 years or older.
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The FDA has approved Xeglyze (abametapir) lotion, 0.74%. Xeglyze is indicated for the topical treatment of head lice infestation in patients aged 6 months and older. Xeglyze should be used in the context of an overall lice management program.
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The FDA has approved Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for the treatment of cataplexy or excessive daytime sleepiness in patients aged 7 years and older with narcolepsy. Xywav is the first FDA-approved new treatment option indicated for both cataplexy and excessive daytime sleepiness in people living with narcolepsy in more than 15 years.
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FDA New Indications
The FDA approved Bavencio (avelumab) for maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy.
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The FDA approved proved Dovato (dolutegravir/lamivudine) as a complete regimen for the treatment of HIV-1 infection to replace the current antiretroviral (ARV) regimen in adults who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable ARV regimen with no history of treatment failure and no known resistance to the individual components of Dovato.
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The FDA approved Epidiolex (cannabidiol) oral solution for the treatment of seizures associated with tuberous sclerosis complex (TSC) in patients aged one year or older. Epidiolex was previously approved for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome. This is the only FDA-approved drug that contains a purified drug substance derived from cannabis. It is also the second FDA approval of a drug for the treatment of seizures associated with TSC.
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The FDA approved Qutenza (capsaicin) 8% intradermal skin patch for the treatment of neuropathic pain associated with diabetic peripheral neuropathy of the feet in adults. Qutenza is a topical, nonsystemic, nonopioid pain treatment that first got approval in 2009 for the treatment of postherpetic pain.
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The FDA has approved the supplemental new drug application for Spravato (esketamine) CIII nasal spray, taken with an oral antidepressant, to treat depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior. Spravato is the first and only approved medicine that has been shown to reduce depressive symptoms within 24 hours.
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The FDA has approved an expanded indication for Stelara (ustekinumab) as a treatment for pediatric patients (aged 6-11 years) who struggle with skin lesions or plaques associated with moderate to severe plaque psoriasis (PsO). Stelara targets both interleukin (IL)-12 and IL-23, two cytokines thought to play an important role in modulating the overactive inflammatory response in a number of autoimmune conditions, including PsO.
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The FDA approved Tecentriq (atezolizumab) in combination with cobimetinib and vemurafenib for patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.
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Ferring DDAVP and Stimate Nasal Spray
Ferring Pharmaceuticals is voluntarily recalling all lots on the market of DDAVP nasal spray 10mcg/0.1mL, desmopressin acetate nasal spray 10mcg/0.1mL and Stimate nasal spray 1.5mg/mL, to the consumer level. These products are being recalled due to superpotency or amounts of desmopressin higher than specified. These out-of-specification results were obtained during routine testing.
Learn more about the Ferring DDAVP and Stimate nasal spray recall
Fresenius Kabi Dexmedetomidine HCl
Fresenius Kabi is voluntarily recalling two lots of dexmedetomidine HCl in 0.9% sodium chloride injection, 200mcg/50mL (4mcg/mL), 50mL fill in a 50mL vial. Fresenius Kabi initiated this recall due to the possibility of a trace amount of lidocaine present in these two lots, and investigation indicates that this issue is limited to these two product lots. This recall is being performed to the user level.
Learn more about the Fresenius Kabi dexmedetomidine HCl recall
Granules Pharmaceuticals Metformin HCl
Granules Pharmaceuticals is voluntarily recalling twelve lots of metformin HCl extended-release tablets USP, 750mg, 100 and 500 count bottles within expiry to the consumer level due to the detection of N-Nitrosodimethylamine levels above the acceptable daily intake limit.
Learn more about the Granules Pharmaceuticals metformin HCl recall
InHe Manufacturing and MHR Brands Products
InHe Manufacturing and MHR Brands voluntarily recalled multiple products due to potential health risks for excess lead. Products include both human and pet hemp tinctures and drops.
Learn more about the InHe Manufacturing and MHR Brands products recall
Summitt Labs Kore Organic Watermelon CBD Oil
Summitt Labs is voluntarily recalling Lot #730 Batch #K018 of Kore Organic Watermelon CBD Oil Tincture, 30mL bottle, 15mg 450x, to the consumer level. The Florida Department of Agriculture and Consumer Services tested a random sample and found the product to contain lead levels at 4.7 ppm. When informed of this, Summitt Labs issued an immediate voluntary recall and started an internal investigation.
Learn more about the Summitt Labs Kore Organic Watermelon CBD Oil recall
Wellements Iron Drops
Wellements is issuing a voluntary recall of two lots of its 1 oz./30mL bottle of Iron Drops (UPC 729609000098) liquid dietary supplement and the sample version being Iron Drops Sample liquid dietary supplement because they may contain an undeclared milk allergen. People who have an allergy or severe sensitivity to milk allergens run the risk of serious allergic reaction if they consume these products.
Learn more about the Wellements Iron Drops recall
FDA Recommends Healthcare Professionals Discuss Naloxone with Certain Patients
The FDA has issued recommendations for healthcare professionals to discuss naloxone with all patients when prescribing opioid pain relievers or medicines to treat opioid use disorder. Healthcare providers should consider prescribing naloxone to those at increased risk of opioid overdose. The FDA is also now requiring that labeling for opioid pain medicine and medicine to treat opioid use disorder be updated to recommend that as a routine part of prescribing these medicines, healthcare professionals should discuss the availability of naloxone with patients and caregivers, both when beginning and renewing treatment.
Learn more about the FDA recommendations for discussing naloxone with certain patients
Hand Sanitizers Consumers Should Not Use
The FDA continues to warn consumers and healthcare providers not to use certain alcohol-based hand sanitizers due to the dangerous presence of methanol (wood alcohol) or 1-propanol. Methanol can be toxic when absorbed through the skin or ingested and can be life-threatening when ingested. 1-propanol, not to be confused with 2-propanol/isopropanol/isopropyl alcohol, is not an acceptable ingredient for hand sanitizer products marketed in the US and can be toxic and life-threatening when ingested.
Learn more about hand sanitizers consumers should not use
Several Companies Voluntarily Recall Extended-Release Metformin
The FDA is alerting patients and healthcare professionals to several voluntary recalls of extended-release metformin. The companies are recalling metformin due to the possibility the medicines could contain nitrosodimethylamine above the acceptable intake limit.
Learn more about several companies voluntarily recalling extended-release metformin
Warning to Companies Illegally Selling Hangover Remedies
The FDA announced it has issued warning letters to seven companies for illegally selling unapproved products labeled as dietary supplements that claim to cure, treat, mitigate, or prevent hangovers, in violation of the Federal Food, Drug, and Cosmetic Act. The warning letters were issued to Double Wood LLC; Ebnsol Inc.; Vita Heaven LLC (dba Hangover Heaven); Happy Hour Vitamins; LES Labs; Mind, Body & Coal LLC; and Purple Biosciences LLC.
Learn more about the warning to companies illegally selling hangover remedies
Warning to Company Selling Fraudulent COVID-19 Related Products
The FDA issued a warning letter jointly with the FTC to one company for selling fraudulent COVID-19 related products. The company, Vapore, LLC, dba Mypurmist, sells Mypurmist with misleading claims that the product can mitigate, prevent, treat, diagnose, or cure COVID-19 in people.
Learn more about the warning to company selling fraudulent COVID-19 related products